Clinical application of disposable cholangiopancreatoscope to bile duct diseases (with video) / 中华消化内镜杂志

ABSTRACT

Objective:To evaluate the safety, efficacy and performance of disposable cholangiopancreatoscope in the diagnosis and treatment of bile duct diseases.Methods:A total of 20 subjects were selected and 16 subjects were enrolled in the prospective and exploratory clinical study which were performed in the Digestive Endoscope Center of Hangzhou First People's Hospital Affiliated to Zhejiang University School of Medicine from July 2021 to August 2021. The disposable cholangiopancreatoscope was used to diagnose bile duct diseases in routine endoscopic retrograde cholangiopancreatography. Biopsies were performed in cases where malignancy was considered. The use related indexes and performance indexes of the instruments were analyzed.Results:Among the 16 patients, there were 6 cases of biliary space-occupying lesions, 6 cases of biliary calculi, and 4 cases of benign biliary stricture before operation. The success rate of the disposable insertion was 100.00% (16/16), and the success rate of observation was 100.00% (16/16). Three biliary space-occupying lesions diagnosed as malignant tumor under cholangiopancreatoscope were confirmed by pathology after operation. Diagnosis of other patients was consistent with preoperative diagnose, so no biopsy was conducted. The rate of positive feedback from operators in directional control was 81.25% (13/16), the image failure rate was 18.75% (3/16), and the rate of positive feedback for image clarity was 93.75% (15/16). In terms of clinical performance, the imaging quality of excellence was 93.75% (15/16), the flexible degree of excellence was 81.25% (13/16), and other indexes were all 100.00% excellence. During the period, there were no instrument defects, pancreatitis, perforation, bleeding or other instrument-related adverse events.Conclusion:The effectiveness, safety and performance indexes of domestic disposable cholangiopancreatoscope have reached the standards of clinical application with high pixel, integration, and portability. It's worthy of clinical recommendation.